Generics/General
FDA proposes standardization of generics standards
The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.
FDA approves first drug via Competitive Generic Therapy pathway
The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.
Hospitals launch non-profit generics company
Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortages and the increasing prices of drugs.
Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon
Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo and will also part ways with eye care specialist Alcon.
Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug
Novartis is facing a lawsuit for attempts to prevent generic versions of its hypertension treatment Exforge, and Amgen announce it will be suing Accord Healthcare for patent infringement on its thyroid drug Sensipar.
FDA significantly increases generic user fees in 2019
The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal year (FY) 2019 compared to 2018.
Generics applications under review by EMA – June 2018
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
MSF challenges hepatitis C patent in China
Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.
UK investigates price increases for generics
In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) has carried out an investigation into the causes of the increases.
FDA publishes list of companies that block generics
The US Food and Drug Administration (FDA) announced on 17 May 2018 that it had published a list of companies that block generics.
